BEUDAMED
    FDA Adverse Event Other Summary report: N

    1 CORODYN P 1

    MDR report key: 727862 · Received June 16, 2006

    Report

    Report Number
    2243801-2006-00018
    Event Type
    Other
    Date Received
    June 16, 2006
    Date of Event
    May 17, 2006
    Report Date
    June 12, 2006
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE UNIT RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED UNITS SHOWS BOTH BALLOON BANDS FULLY INTACT. A 1.5CC SYRINGE IS ATTACHED TO THE BALLOON EXTENSION. THE CATHETER UNIT CONTAINS NO BALLOON, ONLY THE BANDS. VISUAL INSPECTION OF THE BANDS SHOW THAT BANDS ARE CLEAN CUT AT BOTH THE DISTAL AND PROXIMAL END. THERE ARE NO JAGGED EDGES. THE CATHETER UNIT IS ALSO VERY CLEAN, WITH NO INDICATION THAT THE UNIT WAS USED IN VIVO. THE HOUSE RETAIN SAMPLE WAS PHYSICALLY TESTED AND THE REPORTED DEFECT COULD NOT BE REPRODUCED. NO MANUFACTURING DEFECTS COULD BE DETECTED IN THE RETURNED UNIT. THEREFORE NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    DURING THE RIGHT HEART, CATHETER EXAMINATION IN THE POSITION RV, THE BALLOON DISAPPEARED IN THE REDIOGRAPH. AFTER THIS, THE CATHETER WAS REMOVED. A PIECE OF THE BALLOON WAS MISSING. THE REST OF THE BALLOON COULDN'T BE FOUND AT THE FOLLOWING EXAMINATION. WITH CINTRAST MEDIUM IN THE HEART OF THE PT. THE PT IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 CORODYN P 1 WEDGE PRESSURE BALLOON FLOATATION CATHETER DYG B. BRAUN MEDICAL, INC. WP1107U 60764836

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other